Does Ethyl Chloride Spray Work?

NCT06651788 | Recruiting

• 1 other identifier: IRB23-2039
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.

Conditions

Injection Fear; Injection Pain Prevention; Injection Complication

Keywords

Injection; Freeze spray; corticosteroid injections; Ethyl chloride; Orthopeadics

Outcome Measures

Primary Outcomes (4)

• To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores before injection

  Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.

  10 minutes before subject receives injection

• To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores after injeciton

  Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.

  10 minutes after subject receives injection

• To assess patient perception of freeze spray efficacy in decreasing anxiety regarding injections.

  Using the treatment satisfaction questionnaire for medication-II to ask patients their anxiety and if freeze spray usage before corticosteroid injections significantly reduces patient anxiety during the procedure.

  10 minutes after subject receives injection

• To assess their current overall status compared to their pre-injection baseline

  Using the single assessment numeric evaluation (0% furthest from normal and 100% normal) to ask patients their current status

  10 minutes after subject receives injection

Study Arms (3)

Freeze spray group

EXPERIMENTAL

Ethyl Chloride Usage Prior to Orthopaedic Injections

Other: Ethyl Chloride

Placebo application of cold saline spray

PLACEBO COMPARATOR

Saline spray before injection

Other: Cold Saline Spray

No spray prior to injection

NO INTERVENTION

No intervention before injection

Interventions

Ethyl Chloride OTHER

Topical anesthetic that rapidly cools the skin and underlying tissues

Freeze spray group

Cold Saline Spray OTHER

placebo application of cold saline spray

Placebo application of cold saline spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Receiving a corticosteroid injection in an upper or lower extremity (to include soft tissue and joint injections) for the first time

You may not qualify if:

• Patients with previous injection experiences

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (4)

• Randall DJ, Zhang Y, Li H, Hubbard JC, Kazmers NH. Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population. J Hand Surg Am. 2022 Jul;47(7):645-653. doi: 10.1016/j.jhsa.2022.03.009. Epub 2022 May 27.

  PMID: 35644742 BACKGROUND

• Edwards C, Noah C. A Randomized, Double-Blind Trial to Determine if Vapocoolant in the Adult Population Improves Patient Perception of Pain With Peripheral Intravascular Access. Adv Emerg Nurs J. 2017 Oct/Dec;39(4):288-294. doi: 10.1097/TME.0000000000000165.

  PMID: 29095180 BACKGROUND

• Franko OI, Stern PJ. Use and Effectiveness of Ethyl Chloride for Hand Injections. J Hand Surg Am. 2017 Mar;42(3):175-181.e1. doi: 10.1016/j.jhsa.2016.12.013.

  PMID: 28259274 BACKGROUND

• Morote Robles J, Lorente JA, Reig C, Lopez Pacios MA, de Torres JA, Soler Rosello A. [The clinical and prognostic value of inversion of the PSA/PAP ratio in prostatic cancer]. Actas Urol Esp. 1994 May;18(5):559-61. Spanish.

  PMID: 7521563 BACKGROUND

MeSH Terms

Conditions

Iatrophobia

Interventions

Ethyl Chloride

Intervention Hierarchy (Ancestors)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Central Study Contacts

Jennifer M Wolf, MD, PhD

CONTACT

773-834-3531; jwolf@bsd.uchicago.edu

Jordan Swindle, MD

CONTACT

jordan.swindle@uchicagomedicine.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study will be double-blinded to minimize bias. After selection into either spray group the cans will be disguised only showing a number 1 or number 2. Given that the freeze spray is a skin refrigerant, the saline placebo will be refrigerated to mimic the temperature on the skin. The freeze spray is odorless, as is saline, so should not pose a different in smell experience. Neither the participants or physicians will be unblinded at any point; the unblinded investigator will be the only person with access to unblinded data..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the freeze spray group (receiving freeze spray before the injection)

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 22, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)